Immunic Raises $400M to Fund Phase 3 ENSURE MS Trials and NDA Prep
Immunic secured up to $400 million in a private placement, receiving an initial $200 million to complete its Phase 3 ENSURE relapsing MS trials and prepare for a vidofludimus calcium commercial launch. The funding also supports NDA readiness and initiates a Phase 3 primary progressive MS study.
1. Financing Details
Immunic closed a private placement securing up to $400 million, with $200 million received immediately and the remainder available in a second tranche. The company will use the proceeds to fund completion of its twin Phase 3 ENSURE studies in relapsing multiple sclerosis and to underpin preparations for a potential commercial launch of vidofludimus calcium.
2. Phase 3 ENSURE Program
The ENSURE program comprises two identical multicenter trials enrolling a total of 2,200 patients with relapsing MS. An interim analysis in 2024 led the Independent Data Monitoring Committee to recommend continuation as planned. Topline efficacy and safety data from the four-year studies are expected by year-end, representing the primary catalyst for regulatory filings and investor updates.
3. Future Development Plans
Beyond ENSURE readouts, Immunic intends to prepare a New Drug Application submission by mid-next year based on the Phase 3 data. In parallel, the company plans to initiate a Phase 3 trial in primary progressive MS, targeting an area with significant unmet need and limited therapeutic options to broaden vidofludimus calcium’s market potential.